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Notification report


General information

Notification Number
B/DE/10/210

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
08/09/2010

Title of the Project
Evaluation of pollen spread of plastid located genes for the model plant Nicotiana tabacum ”Petit Havanna” under field conditions

Proposed period of release:
01/04/2012 to 31/10/2016

Name of the Institute(s) or Company(ies)
University of Rostock, Agrar- und Umweltwissenschaftliche Fakultät
Agrobiotechnologie
Justus-von-Liebig-Weg 8
Universität Rostock
18059 Rostock;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
tobaccosolanaceaenicotiananicotiana tabacumtabacumPetit Havanna

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes for aadA (from E.coli encode for an Aminoglycosid-Adenyltransferase and confers resistance against antibiotics Streptomycin and Spectinomycin) and gfp (from Aequoria victoria encodes for the green fluorescence protein) were introduced into tobacco plastids each under the control of a different plastid specific promoter from tobacco.

Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
aadA: under control of the psbA promoter (a promoter of the plastidic psbA gene in Nicotiana tabacum) encodes an Aminoglycosid-Adenyltransferase to confer resistance against antibiotics Streptomycin and Spectinomycin, tpsbA terminator of the plastidic psbA gene in Nicotiana tabacum.
gfp: under control of the Prrn promoter (the promoter of the plastidic ribosomal RNA-operon with shine-Dalgarno sequence of the plastidic rbcL gene in Nicotiana tabacum) encodes for the green fluorescence protein of Aequoria victoria; trps16 terminator of the plastidic rps16 gene in Nicotiana tabacum.


6. Brief description of the method used for the genetic modification:
Leaf discs of Nicotiana tabacum var. Petit Havanna were used for plastid transformation by particle bombardment. The selection of shoots was performed by the method described by Svab & Maliga 1993. Three additional selection and regeneration steps where performed for elimination of plastidic wild type DNA. Homoplasmie was verified via RFLP analysis according to Ruf et al. 2007.
Svab Z, Maliga P (2007). Exceptional transmission of plastids and mitochondria from the transplastomic pollen parent and its impact on transgene containment. Proceedings of the National Academy of Sciences of the United States of America 104:7003-7008.
Ruf S, Karcher D, Bock R (2007): Determining the transgene containment level provided by chloroplast transformation. PNAS Vol.104, 17, 6998–7002.


7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable.

Experimental Release

1. Purpose of the release:
Evaluation of the new technological properties and ingredients of the genetically modified tobacco with focus of evaluation of paternal inheritance rate of tobacco plastids dependent on environmental conditions.

2. Geographical location of the site:
Thulendorf (Mecklenburg-Vorpommern)
Ausleben/Üplingen (Sachsen-Anhalt)


3. Size of the site (m2):
2012: no more than 0,3 ha for each release site
2013: no more than 0,3 ha for each release site
2014: no more than 0,3 ha for each release site
2015: no more than 0,3 ha for each release site
2016: no more than 0,3 ha for each release site


4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
Not applicable.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
There is no scientific reason to assume that the synthesis of AADA and GFP as new properties of tobacco may lead to changes in reproduction, dispersion, persistence or invasiveness of these plants compared to conventional tobacco plants. On basis of current experience the transgenic plants do not differ from non-transgenic plants in growth, size, phenotype and seed formation. Under field conditions there is no selective pressure known that might lead to a selective advantage of any of the transgenic lines. Due to current experience no effect of the proteins in the plants on pest or beneficial organisms or on health and environment is expected.

Brief description of any measures taken for the management of risks:
During the release period the Field Manager and trained personnel will monitor the trial site at least once a month. Harvesting machinery will be cleaned on site to prevent the dispersal of GM seeds. Harvested plant material will be transported from the site in closed and labelled containers to the laboratories for analyses. The area will be controlled for volunteers for one consecutive year once a month during the vegetation period. The monitoring period will be prolonged for another year in case transgenic volunteers are detected.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The field trials are designed to investigate the environmental impacts:
- whether the probability of paternal inheritance measured for this tobacco variant in the greenhouse of 2.86 X 10-6 (Ruf et al. 2007) can be found to other environmental conditions
- whether the unintended distribution of transgenes by cross-pollination with conventional crops can be reduced due to their localisation in the plastid genome


Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/05/2012 00:00:00
Remarks: